Patients presenting to hospital with an acute asthma exacerbation severe enough to require admission would receive full standard treatment according to British Thoracic Society guidelines in addition they would be offered the opportunity to take part in the study which would requite them to take a capsule of either montelukast or placebo.

Difference in peak flow between active and placebo limbs by the morning after randomization [ Time Frame: 24 hours maximum ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time (hours) to achieve PEF and FEV greater than or equal to 75% best achieved in the last 12 months with greater than or equal to 25% diurnal variation [ Time Frame: 24 hours maximum ] [ Designated as safety issue: No ]

Time to discharge from hospital [ Designated as safety issue: No ]

PEF, FEV and FVC (as % best/predicted) the morning following admission and at 4 week clinic follow up [ Designated as safety issue: No ]

Proportion of days (post discharge until follow up) with a PEFR of less than or equal to 75%, and less than or equal to 50% best predicted [ Designated as safety issue: No ]

Proportion of days (post discharge until follow up) with a PEFR variability of greater than or equal to 25% [ Designated as safety issue: No ]

Residual volume as % predicted and RV/TLC% and FEF50 and FEF75 at 4 week out patient visit [ Designated as safety issue: No ]

requirement for further medical intervention / increases in treatment following discharge [ Designated as safety issue: No ]

Evaluation of quality of life over the four week out patient follow up period and expressed preference to continue on study medication [ Designated as safety issue: No ]

Evaluation of economic costs and savings from the additional treatment [ Designated as safety issue: No ]

1 study capsule at study entry Montelukast 10mg and a further study capsule at 10pm for four weeks

Drug: Montelukast

1 study capsule at study entry Montelukast 10mg and a further study capsule at 10pm for four weeks

Other Name: Singulair

Placebo Comparator: Placebo

Drug: Placebo

1 placebo capsule at study entry and a further placebo capsule at 10pm for four weeks

Eligibility

Ages Eligible for Study:

18 Years to 50 Years

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Acute Asthma exacerbation requiring hospitalisation

Exclusion Criteria:

Smoking history greater than or equal to 10 pack years

Presenting PEFR greater than or equal to 75% predicted / best

Failure to demonstrate greater than or equal to 15% variability in PEFR or FEV during the study

Any significant and active pulmonary pathology other than asthma

Pregnancy or breastfeeding

Intended pregnancy or inability to take adequate precautions against conception

Patient already on Montelukast

Patient already on Phenobarbitone

Patient already on Rifampicin

Patient already on Phenytoin

Chronic airflow limitation

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01011452